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SPI Pharma
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ABOUT THIS PAGE
15
PharmaCompass offers a list of Granisetron Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Granisetron Hydrochloride manufacturer or Granisetron Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Granisetron Hydrochloride manufacturer or Granisetron Hydrochloride supplier.
PharmaCompass also assists you with knowing the Granisetron Hydrochloride API Price utilized in the formulation of products. Granisetron Hydrochloride API Price is not always fixed or binding as the Granisetron Hydrochloride Price is obtained through a variety of data sources. The Granisetron Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Granisetron HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Granisetron HCl, including repackagers and relabelers. The FDA regulates Granisetron HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Granisetron HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Granisetron HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Granisetron HCl supplier is an individual or a company that provides Granisetron HCl active pharmaceutical ingredient (API) or Granisetron HCl finished formulations upon request. The Granisetron HCl suppliers may include Granisetron HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Granisetron HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Granisetron HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Granisetron HCl active pharmaceutical ingredient (API) in detail. Different forms of Granisetron HCl DMFs exist exist since differing nations have different regulations, such as Granisetron HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Granisetron HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Granisetron HCl USDMF includes data on Granisetron HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Granisetron HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Granisetron HCl suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Granisetron HCl Drug Master File in Japan (Granisetron HCl JDMF) empowers Granisetron HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Granisetron HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Granisetron HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Granisetron HCl suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Granisetron HCl Drug Master File in Korea (Granisetron HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Granisetron HCl. The MFDS reviews the Granisetron HCl KDMF as part of the drug registration process and uses the information provided in the Granisetron HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Granisetron HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Granisetron HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Granisetron HCl suppliers with KDMF on PharmaCompass.
A Granisetron HCl CEP of the European Pharmacopoeia monograph is often referred to as a Granisetron HCl Certificate of Suitability (COS). The purpose of a Granisetron HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Granisetron HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Granisetron HCl to their clients by showing that a Granisetron HCl CEP has been issued for it. The manufacturer submits a Granisetron HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Granisetron HCl CEP holder for the record. Additionally, the data presented in the Granisetron HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Granisetron HCl DMF.
A Granisetron HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Granisetron HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Granisetron HCl suppliers with CEP (COS) on PharmaCompass.
A Granisetron HCl written confirmation (Granisetron HCl WC) is an official document issued by a regulatory agency to a Granisetron HCl manufacturer, verifying that the manufacturing facility of a Granisetron HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Granisetron HCl APIs or Granisetron HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Granisetron HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Granisetron HCl suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Granisetron HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Granisetron HCl API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Granisetron HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Granisetron HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Granisetron HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Granisetron HCl suppliers with NDC on PharmaCompass.
Granisetron HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Granisetron HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Granisetron HCl GMP manufacturer or Granisetron HCl GMP API supplier for your needs.
A Granisetron HCl CoA (Certificate of Analysis) is a formal document that attests to Granisetron HCl's compliance with Granisetron HCl specifications and serves as a tool for batch-level quality control.
Granisetron HCl CoA mostly includes findings from lab analyses of a specific batch. For each Granisetron HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Granisetron HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Granisetron HCl EP), Granisetron HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Granisetron HCl USP).
